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Johnson & Johnson Subsidiary McNeil PPC Inc. Pleads Guilty to Selling Children’s Medicine Containing Metal Particles

According to Law360, a unit of the healthcare giant Johnson & Johnson pleaded guilty Tuesday to a federal criminal charge for selling infants’ and children’s medicine containing metal particles. The subsidiary—McNeil PPC Inc.—must pay a $20 million criminal fine and forfeit $5 million.

Unsealed court documents say metal particles, including nickel, iron, and chromium, were introduced into bottles of Infants’ and Children’s Tylenol and Children’s Motrin during the manufacturing process at McNeil’s plant. Prosecutors alleged that McNeil knew about the problem, but failed to fix it; and instead, continued making the liquid medicines for several more months. Eventually, McNeil traced the problem to the machinery at its plant in Fort Washington, Pennsylvania, spurring a recall in which the FDA advised consumers to stop using the medicine.

On Tuesday, the U.S. Department of Justice announced it was charging the company with selling infants’ and children’s over-the-counter drugs that were adulterated. According to the criminal charge, the medicines were adulterated because they were not manufactured in conformance with Good Manufacturing Practices (cGMP), in violation of the federal Food, Drug and Cosmetic Act (FDCA). McNeil pleaded guilty to the criminal charge and must pay a $20 million criminal fine.

McNeil’s Fort Washington plant was closed in April 2010 after facing several recalls of Tylenol and other drugs for children and adults. In 2011, a United States District Court entered a permanent injunction requiring the company to make certain “remedial measures” before it can reopen. It has yet to reopen.

 

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